Pharmaceutical Company Recruitment 2018

Multi-national pharmaceutical company seeks to employ a Manager: Quality Operations reporting to the Executive – Quality Operations SSA.

Job Description

Job Title: Manager: Quality Operations

Job Purpose:

Manage the Quality Operations team in meeting the company’s objectives in terms of Vendor management, Change control management, Pre-launch activities, and supporting other business units with specific projects, while operating in compliance with company standards.

Organisational Chart:

• Director – Quality Assurance
• Executive – Quality Operations SSA
• Manager: Quality Operations

Key Accountabilities:

Manages compliance with regards to GxP (GMP, GDP & GLP, etc) * Manages and supports the implementation and maintenance of a Quality Management System (QMS) aligned with or exceeding the requirements stated in the SA Guide to GMP and ISO 13485/9001, cognisant of the company corporate requirements, for: Vendor Compliance, Change Control/Change Requests, Product Launch, Dossier Development (CAMS), QA Due Diligence & by means of relevant SOP’s and Policy review and approval.

Further responsibilities:

Vendor Compliance * Change Control/Change Requests * Manage the CC/CR process, ensuring that SLA’s are maintained, without compromising product availability * Manage the CC/CR log, ensuring follow up and resolution of open CC’s within agreed timelines * Ensure that required data is generated by the manufacturing site and is available for dossier submission * Master Documentation * Product Launch * Dossier Development * Supports Quality Operations Executive SSA/HR/personnel compliance and best practices: Develop cross functional and stakeholder relationships, develop and implement budgets for the Quality Operations functions so that the cost and quality objectives are met.

Educational qualifications:

• Tertiary Degree or Diploma – Health or Life Sciences, Quality, Chemistry.

Relevant experience:

• QA experience in a Pharmaceutical Company for 3-5 years with involvement in QA activities.
• Experience in a Pharmaceutical manufacturing facility.
• Regulatory Affairs experience advantageous.
• People management experience for at least 2 years.
• Experience in performing audits.

Salary negotiable depending on experience.

Please email your CV to response “@” mvgrecruitment.co.za or call 0860 100 684 or fax 086 575 0166.